MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-08 for PRISMAFLEX TPE 115315 manufactured by Gambro Industries.
[35693034]
Unknown
Patient Sequence No: 1, Text Type: N, H10
[35693035]
A patient in china was treated with therapeutic plasma exchange (tpe) which included a prismaflex tpe2000 set and a prismaflex machine. At the time of treatment start an external blood leak (estimated at 3 ml) was reportedly observed on the tpe2000 set at the connection of the return line. An unknown machine alarm was reportedly generated and treatment was discontinued.
Patient Sequence No: 1, Text Type: D, B5
[38252739]
Additional manufacturer narrative: the return line from prismaflex tpe2000 ckt set where the leak reportedly occurred has been returned for investigation. A leak test was performed on the return line, which showed that the line was partially unwelded from the connector, allowing the fluid to slightly leak from the line. This subassembly of the prismaflex tpe2000 ckt set is manufactured by one of our suppliers. According to our supplier investigation, no similar complaint was reported regarding the subassembly lot. Based on the measurement performed on the sample, the outer diameter of the tube was within specification. Therefore, the dimension of the tube can be ruled out as a root cause. The subassembly is manually manufactured, the most probable root cause could be an inappropriate way of gluing the line into the connector; using too little glue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010182-2016-00004 |
| MDR Report Key | 5353500 |
| Date Received | 2016-01-08 |
| Date of Report | 2016-02-10 |
| Date of Event | 2015-11-26 |
| Date Mfgr Received | 2015-12-10 |
| Device Manufacturer Date | 2015-05-20 |
| Date Added to Maude | 2016-01-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | THIERRY PALKOVICS |
| Manufacturer Street | 7 AVENUE LIONEL TERRAY |
| Manufacturer City | MEYZIEU |
| Manufacturer Country | FR |
| Manufacturer Phone | 472452525 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRISMAFLEX TPE |
| Product Code | MDP |
| Date Received | 2016-01-08 |
| Returned To Mfg | 2016-01-11 |
| Model Number | 115315 |
| Lot Number | 15E2004 |
| Device Expiration Date | 2018-05-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GAMBRO INDUSTRIES |
| Manufacturer Address | 7 AVENUE LIONEL TERRAY MEYZIEU 69883 FR 69883 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-01-08 |